Stallergenes Greer plc announced topline results for its phase III clinical trial to evaluate the efficacy and safety of its sublingual allergy immunotherapy tablet STAGR320 for the treatment of house dust mite (HDM)-induced allergic rhinitis. The study met its primary endpoint. Results indicated a statistically significant reduction of the Total Combined Score, the sum of the Rhinitis Total Symptom Score and the Rescue Medication Score, in patients treated with STAGR320 compared to patients on placebo. The study also reached key secondary endpoints, including overall quality of life, and showed that the treatment was generally well tolerated, confirming the favorable safety profile observed in previous studies. This was the larger phase III study to evaluate the treatment of HDM-induced allergic rhinitis in adult and adolescent patients, recruiting more than 1,600 patients from 231 participating investigative sites in 13 countries. Allergic rhinitis is a worldwide disease affecting more than 500 million people and the risk of developing asthma is about six times higher in patients with an allergy to house dust mites than those allergic to pollens. Allergic rhinitis can include symptoms such as sneezing, runny or itchy nose, nasal congestion and watery or itchy eyes, among others. Symptoms may be severe and can worsen over time with progression towards asthma, as well as have a significant impact patients’ quality of life. The multi-center, randomized, double-blind and placebo-controlled study evaluated the efficacy and safety of STAGR320 at a daily dose of 300IR administered for approximately 12 months to adult and adolescent patients aged 12-65 with HDM-associated allergic rhinitis. The study met its primary efficacy endpoint and demonstrated a statistically significant difference (p<0.0001) on the Total Combined Score (TCS) after one year of treatment in the treated group versus placebo. The TCS combined the Rhinitis Total Symptom Score (RTSS) and the Rescue Medication Score (RMS). In addition, all key secondary endpoints achieved statistical significance and, overall, the product was well tolerated. The phase III trial was a global, multi-center, randomized, double-blind and placebo controlled study. It evaluated the efficacy and safety of STAGR320 at a daily dose of 300IR administered to adult and adolescent patients aged 12-65 with HDM-induced allergic rhinitis. Patients who experienced HDM-associated allergic rhinitis for at least one year, who were sensitized to D. pteronyssinus and/or D. farinae mites as determined by a skin prick test and HDM-specific serum immunoglobulin E, were eligible for participation. STAGR320 is Stallergenes Greer’s investigational sublingual allergy immunotherapy (AIT) tablet for the treatment of HDM-induced allergic rhinitis. AIT is a disease-modifying treatment that treats the underlying cause of allergy and can provide long-lasting reduction of allergy symptoms. STAGR320 is registered in Australia, Japan, New Zealand and South Korea. Results from the recent phase III trial, together with other clinical data, will form the clinical basis for the company’s potential submission of a Biologics License Application (BLA) in the United States, as well as for additional marketing authorizations in European and international markets.